Eli Lilly Cork is a 12-month contract position in the therapeutic area of Cardiometabolic Health.
This role is part of the Clinical Development (CD) organization and provides leadership and direction for the consultants, associates and assistants supporting trials, ensuring a high performance team culture and cross-functional collaboration to achieve clinical development goals within the broader Clinical Design Delivery Analytics (CDDA) organization.
The Manager collaborates with the Clinical Development Advisor to ensure trial-level planning and execution align with strategy and timelines, and maintains clinical operational oversight of regional/global study level deliverables including trial enrollment targets, with compliance to regulations and clear process implementation.
Responsibilities
Business Planning
Partners with functional, cross-functional and team leadership to provide operational input into feasibility and resource requirements for clinical plans.
Provides strategic direction and leadership to CTPMs to implement the Regional/Global enrollment strategy and achieve milestones; escalates issues for awareness and resolution.
Collaborates with Medical Sourcing, Procurement, CPM, and the compound Team Management on internal/external-sourcing options.
Works with the clinical project manager to ensure planning databases are accurate and up-to-date.
Resource Management
Aligns resources based on team priorities and regional trial participation.
Manages study management personnel workload by portfolio, global/regional requirements and individual expertise.
Facilitates discussions with functional counterparts to manage priorities and unplanned demands.
Recruits, retains and develops top talent to sustain a high performing team culture.
Trial Management Expertise
Facilitates problem-solving, shared learning and decision-making across clinical functions.
Participates in risk assessments at the clinical plan level and develops cross-functional risk management plans at the trial level.
Ensures inspection readiness of study teams; coaches CTPMs in timely documentation of deviations and preparation of issue summaries for high-risk topics.
Oversees appropriate personnel involvement when compliance issues arise requiring action or follow-up.
Training and Compliance
Maintains curriculum maps and training programs/courses with the training group; consults on new training programs as appropriate.
Ensures team members complete trainings related to GCPs, global SOPs, and clinical best practices.
Evaluates CTPMs capabilities and coaches or identifies appropriate coaches to enable proficiency in study responsibilities.
Monitors training compliance for consultants, associates and assistants to ensure timely completion of courses.
Promotes quality in clinical research activities by applying GCPs, SOPs and best practices consistently.
Application/Improvement of Processes
Generates innovative ideas and leads or contributes to new processes and improvements to enhance productivity and quality.
Supports staff to share new learning opportunities or technologies across clinical functions.
Encourages use of metrics to assess program status and identify opportunities for improvement.
Reviews and implements new clinical trial processes and assesses their impact on project goals.
Communication
Partners with cross-functional leadership to resolve clinical trial operational issues.
Facilitates high-level discussions with vendors as appropriate.
Performance Management
Manages performance objectives, progress reviews, feedback and documentation for staff.
Performs salary administration for reporting staff members.
Conducts talent assessment and succession planning for direct reports, handling data with privacy and integrity.
Basic Requirements
Bachelors or University degree (scientific or health-related field preferred) and 5 years clinical research experience or relevant experience; or an advanced degree.
Minimum of 5 years clinical trial experience with strong knowledge of the clinical research process.
Additional Preference
Demonstrated technical and process expertise in clinical trial development; understanding of the drug development process and task interdependencies.
Strong communication skills and ability to maintain confidentiality regarding strategic and personnel matters.
Proven ability to coach others; strong leadership and ability to influence across clinical functions.
Strong interpersonal, teamwork and negotiation skills; good self-management and organizational abilities.
Capability to manage staff virtually across borders and cultures; understanding of cultural differences.
Previous supervisory experience and global clinical trial experience.
Experience with management of business plans and ability to facilitate planning processes across clinical functions.
Additional Information
Travel may be required.
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